For DNDN, it ended up in a CRL, although an advisory committee voted for it.

You are correct in that accepting the review is is essentially meaningless, unless the application is approved, or a definite pathway is defined.

For DNDN that pathway was designing a trial with the secondary outcome as a primary endpoint, with regards to median survival.

I am not sure what, if anything, will come out of any NDA, if it is accepted. My skepticism is appropriately communicated, here for your review:

"We agree with management and we view the probability of regulatory approval being very low, but remotely possible, given the depth of data Depomed could submit"

"We find this possibility highly unlikely [that the application would be approved with] an indication for "short term relief"

"We find it hard to reconcile the FDA's requests for more lengthy data, and simultaneously accept the idea that the FDA would allow an application that does not even meet the 4 and 12 week primary endpoints listed in the 'Guidance to Industry'. We also find it unlikely that the FDA will allow a retroactive analysis of the data for Serada's application, considering both the FDA historic viewpoints and the fact that the hot flash indication is a quality of life issue, and not a condition with a mortality outcome."

--- In summary, I feel that Serada's fate is unfortunate. When the trial design permitted outliers, and had a short run-in period, they weren't able to achieve statistical significance using parametric analysis. When they changed the trial design to reduce outliers and their impact, they weren't able to achieve statistical significance using non-parametric analysis.

So, the drug works. Would it be worth running another trial, that costs $10 million without any updates from the regulatory bodies? I dont think so. But maybe, they can negotiate something from the FDA. The chances are low, and should not be a fundamental reason to own shares. Cash, glumetza, and gralise alone are a compelling reason. I wouldn't hope for Serada, but at this price, it's essentially a free option.

I welcome any other questions about THIS topic. You can find more about me on my website, twitter, or linkedin.

I believe that Dr. Sweeny may have been referencing dendreon's application for Provenge. Although I haven't talked to management yet.

- With regards to DNDN, the FDA accepted their application for review with data from a clinical trial that didn't achieve statistical significance from a primary outcome.

With regards to BNVI the company has stated they plan to initiate a phase three for Menerba, relatively soon.

Your allusion to their cash situation and repeated dilutions have an appropriate skepticism. The phase three trial will cost at least $20 million AND they need two of them. Furthermore, manufacturing and scaling will bean issue for the second trial and the application for approvals well. Standardizing a botanical pharmacotherapy will be challenging, costly, and is essentially unprecedented.

Although their mechanism of action is very compelling, I share your skepticism, many issues moving forward besides the financial you mentioned.

The 'finance' issue is an issue for the majority of small cap biopharma companies. Hence all the "impending" partnerships and "potential buyouts."

Hey, I didnt get a chance to update my position here, I had sold out of DRRX, PTIE about a week before PDUFA. You can follow my comments and reasoning on twitter (basically, I was spooked by Pfizer's CEO comments about manufacturing issues.)

I like the idea of buying a distressed assett, and I am considering buying DRRX and PTIE again. Espeically DRRX which I feel receiving undo punishment.

I would get bullish about PTIE if management could outline in more clarity their path forward. What are the issues with manufcaturing? I haven't gotten around to calling management yet, plenty of other opporunities right now that are more attractive from a fundamental and technical perspective. With that said, I am a fan of buying distressed assetts.

I would be a buyer, if management expresses the timeline and issues in honest.

Walking away from this article, I could tell a professional level of due diligence was done. The issues you raise are complex ones and not for the laypeople on SA, so I would caution you not to take the comments too seriously.

While it's true that use patent are relatively easier to invalid, it doesn't mean that the company can't prove validity. One point to consider, is that PBA has no other treatment, so how could there be sufficient prior art. That's the USE in the use-patent. AVNR had to prove in large RCT it's effectiveness.

So the patent related weakness you identified is pretty much the same for ALL use patents and not AVNR's specifically.

So with that in mind, how many use patents have maintained validity, and how many use patents have maintained validity for treatment with no other treatment EVER defined.

The answers to these questions would be more relevant than what you've discussed, at least in my opinion.

Hey all fit into the category of specialty pharma, all have performed nicely especially NEOP, AMRN, AVNR - to be honest not as versed in these names as the ones I listed.

Best way to analyse is take FY2012 projected sales (they are all launch stage so be conservative) multiply by 2x-3x and then add cash subtract debt, etc - that may give you an idea if where the valuation should be.

Warm Regards. Interested to see when you purchased those names, how long you have held and what your thoughts are. Thanks in advance.

It's 3.5 to 4 times SALES - I think comfortable range for platform/specialty would be 2x to 3x sales. And in the case of launch stage it would be foolish to assume more than 200m $optr $depo $sppi $avnr $xnpt

After 12 months launch potential sales can be better estimated,

Keep in mind these are done on my mobile, so are general:

So for example with $optr $depo $sppi specifically I think fair valuation would be to assume fy2012 annual sales to be $200 million

So all case take 150 for cash, add 400 million ~550 market cap at minimum

Sonqui,Incyte's drug will not likely block YMI's approval. The Orphan drug designation allows 7 years of marketing exclusivity. But this is overridden by the FDAs desire to allow improved drugs on the market a the same time. Improved or better drugs can enter the market during this 7 year period.

This may be a driving factor behind YMIs decision to pursue Anemia response. If also go for spleen reduction, it'd be exact same as Incyte, hence no improvement on treatment.

I am no expert, but that's what I make of the FDAs orphan definitions. Hope it helps.